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临床试验/NCT06785714
NCT06785714已完成不适用

Colorectal Cancer Screening in Xinxiang City

The First Affiliated Hospital of Xinxiang Medical College1 个研究点 分布在 1 个国家目标入组 25,000 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25,000
试验地点
1
主要终点
Sensitivity of colorectal cancer detection

研究概览

简要总结

The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).

详细描述

The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 45-74 years at time of consent
  • Have not had gastrointestinal resection

排除标准

  • Previous history of colorectal cancer
  • Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
  • Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
  • Those with severe mental disorders and language communication disorders
  • History of contraindications to colonoscopy
  • Pregnant women

结局指标

主要结局

Sensitivity of colorectal cancer detection

时间窗: 180 days

Sensitivity of colorectal cancer detection

Specificity of advanced neoplasia detection

时间窗: 180 days

Specificity of advanced neoplasia detection

次要结局

  • Positive predictive value of colorectal cancer detection(180 days)
  • Negative predictive value of colorectal cancer detection(180 days)
  • Sensitivity and specificity of advanced adenoma detection(180 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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